Thoratec Corp.

Complete recall history across all FDA and CPSC categories — 12 total recalls

Thoratec Corp. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (12)

FDA medical device enforcement actions by Thoratec Corp.

Date Product Reason Class
May 8, 2024 Thoratec HeartMate System Monitor, REF: 1286, L1286, 1286A, L1286A, 1286A-US,... System monitor screen may display atypical behavior: Overlapping screens/butt... Class I
Mar 1, 2024 Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly Potential for a leak path at the seal interface between the left ventricle as... Class I
Mar 1, 2024 Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly Potential for a leak path at the seal interface between the left ventricle as... Class I
Feb 19, 2024 HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3 Sealed Out... Observed outflow graft deformation known as Extrinsic Outflow Graft Obstructi... Class I
Feb 19, 2024 HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed O... Observed outflow graft deformation known as Extrinsic Outflow Graft Obstructi... Class I
Jan 3, 2024 1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Comm... Due to software and controller systems that results in unexpected pump start ... Class I
Aug 7, 2023 Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & Heart... Inability to start and/or complete the coring procedure due to inadequate sha... Class II
Oct 22, 2021 Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Re... If LVAS communication system is trying to establish Bluetooth connection and ... Class II
Dec 2, 2019 HeartMate 3 Mobile Power Unit, REF 107754, UDI or GTIN: 00813024010883, and 1... Excessive static electricity can potentially cause unrecoverable power loss a... Class II
Mar 30, 2019 Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only,... Outflow Graft leaking at the pump connection during the implantation process.... Class II
Mar 30, 2019 Thoratec Heartmate 3 Sealed Outflow Graft with Bend Relief, Sterile, REF 1055... Outflow Graft leaking at the pump connection during the implantation process.... Class II
Mar 1, 2019 Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an opti... Small black plastic particle was observed in the left ventricle during implan... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.